510(k) · Cleared
ClearedBurn Resuscitation Decision Support System - Clinical (BRDSS-C)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Surgeon General, Department of the Army · PDT Burn Resuscitation Decision Support Software
Cleared on Dec 23, 2014 as substantially equivalent to K121659 (Arcos, Inc., 2013) after a 312-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Dec 23, 2014
- Review
- 312 days
- Class
- Class II
- Product code
- PDT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K011571 (2001). No later device cites it as a predicate yet.
- Root · 2 generations backK011571 TRXF Intelligent Dosing System (Ids) -Dosing Calculator SuiteThe RX Files Corp. · 2001
- 1 generation backK121659 Burn Resuscitation Decision Support System (Brdss)Arcos, Inc. · 2013 · Recalled
- This deviceK140387 Burn Resuscitation Decision Support System - Clinical (BRDSS-C)The Surgeon General, Department of the Army · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011571 | TRXF Intelligent Dosing System (Ids) -Dosing Calculator Suite | The RX Files Corp. | 2001 | — |
| −1 | K121659 | Burn Resuscitation Decision Support System (Brdss) | Arcos, Inc. | 2013 | 1 |
| 0 (this device) | K140387 | Burn Resuscitation Decision Support System - Clinical (BRDSS-C) | The Surgeon General, Department of the Army | 2014 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PDT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K121659 | Burn Resuscitation Decision Support System (Brdss)Summary page 5…Regulation Number: 21 CFR 868.1890 Classification Name: Predictive pulmonary-function value calculator. Regulatory Class Class II Product Code: PDT Predicate Device: K121659 Burn Resuscitation Decision Support System (BRDSS) Device Description: The Burn Resuscitation Decision Support System — Clinica… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 11.7 years on median.
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All PDT devicesPDT Burn Resuscitation Decision Support Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · PDT
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · PDT
Too few PDT 510(k)s in any year since 2007 to give a median.
Recalls per year · PDT
No recall names PDT since 2007.
Adverse event reports per year · PDT
No MAUDE report names PDT since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The BRDSS-C is indicated for use in the care of adult patients and adolescent patients 17 years of age or older who weigh 40kg (88lbs) or more with 20% or more Total Body Surface Area (TBSA) burned, as a fluid resuscitation calculator for fluid recommendations. The BRDSS-C is intended to be initiated within 24 hours of the burn incident and completed by 72 hours post burn. The BRDSS-C is not indicated for use in patients who are less than 17 years of age.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K140387 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140387: Burn Resuscitation Decision Support System - Clinical (BRDSS-C).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140387
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026